Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females

Phase 1

Terminated

Brief Summary: PK and safety profile of Proellex® in females with various stages of impaired renal function

Detailed Description: The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function

Recruitment & Eligibility

Inclusion Criteria

Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
Subject with renal impairment must have evidence of stable disease
If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
Negative urine pregnancy test at screening visit
Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
Healthy subject must have no significant abnormal findings at the screening physical examination
Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
Additional inclusion criteria may apply

Exclusion Criteria

Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
Subject with clinically significant abnormal liver function
Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
An acute illness within five (5) days of study medication administration
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
Additional exclusion criteria may apply

Arm && Interventions

Group	Intervention	Description
50 mg Proellex Mild impairment	50 mg Proellex	50 mg Proellex single dose Female subjects with mild renal impairment function.
50 mg Proellex, Normal	50 mg Proellex	50 mg Proellex, Female subjects with normal renal function.
50 mg Proellex Moderate	50 mg Proellex	50 mg Proellex, Female subjects with moderate renal impairment function.

Primary Outcome Measures

Name	Time	Method
Cmax of Proellex	48 hours

Secondary Outcome Measures

Name	Time	Method

Locations (4): New Orleans Center for Clinical Research - Knoxville
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Knoxville, Tennessee, United States
DaVita Clinical Research
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Minneapolis, Minnesota, United States
Clinical Pharmacology of Miami, Inc
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Miami, Florida, United States
Orlando Clinical Research Center
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Orlando, Florida, United States